VF9DANAI5Insulin Pump

User Guide. This page left blank intentionally Sooil Development Co.,Ltd. 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Republic of Korea. Tel: 82-2-3463-0041 Fax: 82-2-3463-7707 E-mail: [email protected] http://www.sooil.com MT Promedt Consulting GmbH Altenhofstrasse 80, 66386 St. Ingbert, Germany Tel : 49-6894-581020 Local Distributor / pump specialist 1. Introduction 1. Diabecare DANA-i Insulin Pump Introduction 2. Explanation of Warning Symbols 3. Indications for Use 4. Contradiction 5. Potential Risks 6. Airport Security (Only for US manual) 7. Precautions 2. Getting Started * Components of Diabecare DANA-i System 1. Getting to know the DANA Insulin Pump *Diabecare DANA-i Insulin Pump * Control Panel 2. Installing a battery 3. Display Screen * Initial Screen * Remote control mode * Additional Options 4. Patient Education *About Doctor Mode 3. Programming the Insulin Pump * Structure of Diabecare DANA-i Menu: 1. Adjust the time 2. Setting the Basal Rate * Description of Basal Graph: * How to edit the Basal Rate: 3. View Basal Rate 4. Setting User Options * User Options More Information Screen 4. Loading Insulin into the Pump 1. Preparation 2. Filling the Reservoir with Insulin 3. Adjust the length of linking screw with Auto Setter * Using DANA Auto Setter : 4. Inserting the Reservoir into the Insulin Pump 6 6 6 7 7 7 7 8 11 11 12 12 13 14 16 16 18 18 19 19 21 21 22 23 24 26 28 29 30 33 34 34 36 38 39 40 Table of Contents 5. Connecting the Infusion Set to the Insulin Pump 6. Refill 7. Prime the Infusion Set Tubing * PRIME procedure: 8. Prime the Cannula 9. Reloading the pump * Connection of Pump & Reservoir * Recommending insertion site location 5. Delivering a Bolus * Bolus calculation parameter * Three type of Bolus Delivery 1. Bolus (Quick Bolus) * How to start the (Quick) bolus delivery: * Stop delivery during bolus: 2. BG Bolus Calculator (Smart Bolus) 3. Bolus Setting * Bolus Setting * Pre-set Bolus 6. Advanced features within Pump 1. Temporary Basal Rates * Starting a Temporary Basal Rate * Review Temporary Basal Rate Whilst in Operation * Stopping a Temporary Basal Rate 2. Suspend 3. Button Lock 4. Basal Profile 5. HISTORY : Displays all the Pump History * Review Menu 6. SHIPPING INFORMATION 7. Airplane mode 8. Extended Bolus * Start Extended Bolus (Quick Bolus) * Stop an Extended Bolus 9. Dual Pattern Bolus * Stopping a Dual Pattern Bolus 7. Alarms and Error Messages * WARNING Message * ERROR Message * ALARM Message 41 42 43 44 46 48 49 50 51 51 52 53 54 55 56 58 59 61 63 63 63 64 65 66 67 68 69 70 72 73 74 74 75 76 77 78 79 82 83 8. Troubleshooting 1. Hypoglycemia (low blood sugar) * What is hypoglycemia (low blood sugar)? * Reasons for Hypoglycemia * What to do in case of hypoglycemia * Hypoglycemia Troubleshooting 2. Hyperglycemia (high blood sugar) * What is Hyperglycemia (high blood sugar)? * Reasons for Hyperglycemia * What to do in case of High Blood Sugar * Troubleshooting for Hyperglycemia 3. Occlusion Alarm * Real Occlusion (Usually within the Cannula or tube) * Occlusion caused by external factor 4. Troubleshooting the Insulin Pump 9. Taking care of the System 1. Cleaning the System 2. Disposing of Pump and System 3. Storing the System 10. Specification 1. Insulin Pump 2. Infusion Sets 3. Prime Volume of Infusion Sets * Cannula prime 4. Delivery accuracy 5. Classification and Compliance with Standards 6. Essential Performance 7. Wireless communication * DATA Security * FCC Notice * Declaration of EMC compatibility 8. Explanation of Universal Symbols 10. Index 11. Warranty 88 88 88 88 88 89 90 90 90 90 91 92 92 93 94 95 95 95 96 98 98 99 101 101 102 103 103 104 104 104 105 112 115 116 67 2. Explanation of Warning Symbols 1. Introduction 1. Diabecare DANA-i Insulin Pump Introduction 3. Indications for Use 4. Contraindication 5. Potential Risks The Diabecare DANA-i Insulin Pump herein after will be referred to as ‘Insulin Pump’ throughout the manual. The Diabecare DANA-i Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Diabecare DANA-i Insulin Pump is not intended for use with blood or blood products. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use with NovoLog/NovoRapid U-100 Insulin. The pump is intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery. Insulin Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. • Infection • Skin irritation or redness • Bruising • Discomfort or pain • Bleeding • Irritation • Rash • Hypoglycemia • Hyperglycemia Warning The Diabecare DANA-i system is only to be used by patients who have received training from a certified diabetes educator and/or insulin pump trainer and by advice from a physician. For safety and optimum benefits read the entire user manual before using the system. Caution Read these instructions for use carefully and completely before using this device for the first time. Especially, users who have used other pumps should be cautious. Warning Indicates the presence of a hazard which can cause severe personal injury, death or substantial property damage if the warning is ignored. Caution Indicates the presence of a hazard which will or can cause minor personal injury or property damage if the warning is ignored. Warning Warning Caution Caution Notice Advises the user of installation, operation or maintenance information which is important but not hazard related. 89 1. Pump users need more than 4 blood glucose measurements per day, and vision and hearing to receive any pump alarm.…

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SOOIL Development Co., Ltd. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Date: February 10, 2020 Subject; Request for Confidentiality FCC ID: VF9DANAI5 To Whom It May Concern, Pursuant to the provisions of Sections 0.457 and 0.459 of Commission's rules (47CFR0.457, 0.459), we are requesting the Commission to withhold the following attachment(s) as confidential document from public disclosure indefinitely. • Schematic Diagram • Block Diagram • Part List • Operational Description Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. In additional to above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commission' s policy, in order to comply with the marketing regulations in 47 CFT §2.803 and the importation rules in 47 CFR §2.1204, while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We are requesting the commission to grant shot-term confidentiality request on the following attachment(s) for 180 days after the grant as outlined in Public Notice DA 04-1705. • External Photos • Internal Photos • Test Setup Photos • User Manual It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Sincerely, Name: Geun-Sang, Lim Title: General Manager

Letter of Authorization Company : SOOIL Development Co., Ltd. Address : 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Korea Product Name : Insulin Pump Model Number : Diabecare DANA-i5 FCC Identifier : VF9DANAI5 We authorize MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, to act on our behalf on all matters concerning the above named equipment. Any individual within MiCOM Labs is authorized to act on our behalf and take action on the application. We declare that MiCOM Labs Inc, 575 Boulder Court, Pleasanton, California 94566, USA, is allowed to forward all information related to the approval project to the Federal Communication Commission and to discuss any issues concerning the approval application. Any and all acts carried out by MiCOM Labs on our behalf shall have the same effect as acts of our own. Name: Geun-Sang, Lim Date: February 10, 2020 Title: General Manager Signature of applicant

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Page 1 of 1 Name: Geun-Sang, Lim Title: General Manager IDENTIFICATION LABEL: PROPOSED FCC ID LABEL The FCC ID shall be permanently affixed in the rear side of the equipment

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Page 1 of 7 Report No.: OT-202-RWD-014 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) ELECTROMAGNETIC EMISSION COMPLIANCE REPORT FOR LOW-POWER, NON-LICENSED TRANSMITTER Test Report No. : OT-202-RWD-014 AGR No. : A19NA-063 Applicant : SOOIL Development Co., Ltd. Address : 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Korea Manufacturer : SOOIL Development Co., Ltd (Heukseok) Address : 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Korea Type of Equipment : Insulin Pump FCC ID. : VF9DANAI5 Model Name : Diabecare DANA-i5 Serial number : N/A Total page of Report : 7 pages (including this page) Date of Incoming : December 30, 2019 Date of issue : February 10, 2020 SUMMARY The equipment complies with the regulation; FCC PART 15 SUBPART C Section 15.247 This test report only contains the result of a single test of the sample supplied for the examination. It is not a generally valid assessment of the features of the respective products of the mass-production. Reviewed by: Approved by: Tae-Ho, Kim / Senior Manager Ki-Hong, Nam / General Manager ONETECH Corp. ONETECH Corp. Page 2 of 7 Report No.: OT-202-RWD-014 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) CONTENTS PAGE 1. VERIFICATION OF COMPLIANCE ............................................................................................................................. 4 2. GENERAL INFORMATION ............................................................................................................................................ 5 2.1 PRODUCT DESCRIPTION ................................................................................................................................................. 5 2.2 ALTERNATIVE TYPE(S)/MODEL(S); ALSO COVERED BY THIS TEST REPORT. ................................................................ 5 3. EUT MODIFICATIONS .................................................................................................................................................... 5 4. MAXIMUM PERMISSIBLE EXPOSURE ...................................................................................................................... 6 4.1 RF EXPOSURE CALCULATION ....................................................................................................................................... 6 4.2 TEST RESULT FOR BLUETOOTH LE .............................................................................................................................. 7 Page 3 of 7 Report No.: OT-202-RWD-014 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) Revision History Rev. No. Issue Report No. Issued Date Revisions Section Affected 0 OT-202-RWD-014 February 10, 2020 Initial Release All Page 4 of 7 Report No.: OT-202-RWD-014 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) 1. VERIFICATION OF COMPLIANCE Applicant : SOOIL Development Co., Ltd. Address : 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Korea Contact Person : Geun-Sang, Lim / General Manager Telephone No. : +82-2-2824-2133 FCC ID : VF9DANAI5 Model Name : Diabecare DANA-i5 Brand Name : - Serial Number : N/A Date : February 10, 2020 EQUIPMENT CLASS DTS – DIGITAL TRNSMISSION SYSTEM E.U.T. DESCRIPTION Insulin Pump THIS REPORT CONCERNS Original Grant MEASUREMENT PROCEDURES ANSI C63.10: 2013 TYPE OF EQUIPMENT TESTED Pre-Production KIND OF EQUIPMENT AUTHORIZATION REQUESTED Certification EQUIPMENT WILL BE OPERATED UNDER FCC RULES PART(S) FCC PART 15 SUBPART C Section 15.247 558074 D01 15.247 Meas Guidance v05r02 Modifications on the Equipment to Achieve Compliance None Final Test was Conducted On 10 m, Semi Anechoic Chamber -. The above equipment was tested by ONETECH Corp. for compliance with the requirement set forth in the FCC Rules and Regulations. This said equipment in the configuration described in this report, shows the maximum emission levels emanating from equipment are within the compliance requirements. Page 5 of 7 Report No.: OT-202-RWD-014 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) 2. GENERAL INFORMATION 2.1 Product Description The SOOIL Development Co., Ltd., Model Diabecare DANA-i5 (referred to as the EUT in this report) is an Insulin Pump, Product specification information described herein was obtained from product data sheet or user’s manual. DEVICE TYPE Insulin Pump Temperature Range 1 °C ~ 40 °C Operating Frequency 2 402 MHz ~ 2 480 MHz Modulation Type GFSK RF Output Power 125 kbps: -6.08 dBm 1 Mbps: -6.08 dBm ANTENNA TYPE Chip Antenna ANTENNA GAIN 1.05 dBi List of each Osc. or crystal Freq.(Freq. >= 1 MHz) 32.768 kHz RATED SUPPLY VOLTAGE DC 1.5 V 2.2 Alternative type(s)/model(s); also covered by this test report. -. None 3. EUT MODIFICATIONS -. None Page 6 of 7 Report No.: OT-202-RWD-014 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) 4. MAXIMUM PERMISSIBLE EXPOSURE 4.…

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Page 1 of 57 Report No.: OT-202-RWD-013 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) ELECTROMAGNETIC EMISSION COMPLIANCE REPORT FOR LOW-POWER, NON-LICENSED TRANSMITTER Test Report No. : OT-202-RWD-013 AGR No. : A19NA-063 Applicant : SOOIL Development Co., Ltd. Address : 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Korea Manufacturer : SOOIL Development Co., Ltd (Heukseok) Address : 62, Yonggu-daero 2325beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 16922, Korea Type of Equipment : Insulin Pump FCC ID. : VF9DANAI5 Model Name : Diabecare DANA-i5 Serial number : N/A Total page of Report : 57 pages (including this page) Date of Incoming : December 30, 2019 Date of issue : February 10, 2020 SUMMARY The equipment complies with the regulation; FCC PART 15 SUBPART C Section 15.247 This test report only contains the result of a single test of the sample supplied for the examination. It is not a generally valid assessment of the features of the respective products of the mass-production. Reviewed by: Approved by: Tae-Ho, Kim / Senior Manager Ki-Hong, Nam / General Manager ONETECH Corp. ONETECH Corp. Page 2 of 57 Report No.: OT-202-RWD-013 It should not be reproduced except in full, without the written approval of ONETECH Corp. EMC-003 (Rev.2) ONETECH Corp.: 43-14, Jinsaegol-gil, Chowol-eup, Gwangju-si, Gyeonggi-do, 12735, Korea (TEL: 82-31-799-9500, FAX: 82-31-799-9599) CONTENTS PAGE 1. VERIFICATION OF COMPLIANCE ............................................................................................................................. 5 2. TEST SUMMARY .............................................................................................................................................................. 6 2.1 TEST ITEMS AND RESULTS ............................................................................................................................................. 6 2.2 ADDITIONS, DEVIATIONS, EXCLUSIONS FROM STANDARDS ........................................................................................... 6 2.3 RELATED SUBMITTAL(S) / GRANT(S) ............................................................................................................................ 6 2.4 PURPOSE OF THE TEST ................................................................................................................................................... 6 2.5 TEST METHODOLOGY .................................................................................................................................................... 6 2.6 TEST FACILITY ............................................................................................................................................................... 6 3. GENERAL INFORMATION ............................................................................................................................................ 7 3.1 PRODUCT DESCRIPTION ................................................................................................................................................. 7 3.2 ALTERNATIVE TYPE(S)/MODEL(S); ALSO COVERED BY THIS TEST REPORT. ................................................................ 7 4. EUT MODIFICATIONS .................................................................................................................................................... 7 5. SYSTEM TEST CONFIGURATION ............................................................................................................................... 8 5.1 JUSTIFICATION ............................................................................................................................................................... 8 5.2 PERIPHERAL EQUIPMENT .............................................................................................................................................. 8 5.3 MODE OF OPERATION DURING THE TEST ...................................................................................................................... 8 5.4 CONFIGURATION OF TEST SYSTEM ............................................................................................................................. 11 5.5 ANTENNA REQUIREMENT ............................................................................................................................................ 11 6. PRELIMINARY TEST .................................................................................................................................................... 12 6.1 AC POWER LINE CONDUCTED EMISSIONS TESTS ....................................................................................................... 12 6.2 GENERAL RADIATED EMISSIONS TESTS ..................................................................................................................... 12 7. MINIMUM 6 DB BANDWIDTH .................................................................................................................................... 13 7.1 OPERATING ENVIRONMENT ......................................................................................................................................... 13 7.2 TEST SET-UP ................................................................................................................................................................. 13 7.3 TEST EQUIPMENT USED ................................................................................................................................................ 13 7.4 TEST DATA FOR 125 KBPS ............................................................................................................................................ 14 7.5 TEST DATA FOR 1 MBPS ........................................…

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